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Medico-economic Evaluation of the Creation of Arteriovenous Access for Hemodialysis Between Surgical Technique and Endovascular Technique in Patients with End-stage Renal Disease
Sponsor: University Hospital, Bordeaux
Summary
This multicenter 1 :1 randomized controlled trial aims at comparing the cost-effectiveness of endovascular arteriovenous fistula (AVF) creation using Ellipsys® and WaveLinQ® devices with traditional surgical AVF creation for hemodialysis. The primary endpoint is the cost-utility ratio (cost per QALY gained), with an anticipated sample size of 252 patients. This study will provide critical insights into the viability and cost-effectiveness of endovascular techniques, potentially shaping future standards of care in hemodialysis access.
Official title: Cost-effectiveness Study Comparing Endovascular and Surgical Arteriovenous Fistula Creation for Haemodialysis in Patients with End-stage Renal Failure
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
252
Start Date
2025-01-15
Completion Date
2030-01-15
Last Updated
2024-11-14
Healthy Volunteers
No
Conditions
Interventions
WaveLinQ® device
The WaveLinQ® system employs a dual catheter technique to establish communication between deep arteries and veins, typically using a ulnar or radial artery and vein. This procedure necessitates fluoroscopic guidance to position the catheters correctly, a control angiogram, and potential embolization to enhance blood flow.
Ellipsys® device
The Ellipsys® system enables the entire AVF creation process to be conducted under ultrasound guidance without the need for fluoroscopy or contrast media. It uses a single needle to puncture the superficial vein, the perforator and the artery and potential balloon angioplasty to enhance blood flow.
No device
Surgical AVF creation will involve a direct approach to the proximal radial, ulnar, or brachial artery to create a 4-6 mm longitudinal arteriotomy. An oblique incision will be made at the elbow crease. The cephalic, basilic, or perforating vein may be used for the side-to-end anastomosis. If a transposition is required due to adiposity, it will be performed either during the same procedure or at a later time through tunneling or lipectomy.
Locations (11)
Centre Hospitalier Universitaire de Bordeaux
Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine - Centre Aquitain des pathologies vasculaire
Bordeaux, France
AP-HP Centre Hospitalier Universitaire d'Ambroise Paré
Boulogne-Billancourt, France
Clinique du parc
Castelnau-le-Lez, France
Centre Hospitalier Universitaire de Dijon - Hôpital le Bocage
Dijon, France
Centre Hospitalier Mutualiste de Grenoble
Grenoble, France
Hôpital privé Jean Mermoz
Lyon, France
Centre Hospitalier St Joseph - St Luc
Lyon, France
Centre Hospitalier Universitaire de Nice - Hôpital Pasteur 1
Nice, France
Groupe Hospitalier Paris St Joseph - Centre Hospitalier Chartres
Paris, France
Centre Hospitalier Universitaire de Nantes - Hôpital Nord Laennec
Saint-Herblain, France